To determine the rate of complete cytogenetic response at 12 months in adult patients with previously untreated high Sokal risk CML treated with imatinib at 2 different dose levels of 400 and 800 mg/daily.

Secondary Outcome Measures:

The rate of major cytogenetic response,the kinetic and duration of cytogenetic response, the time to accelerated and blast crisis and overall survival,safety and tolerability of the treatment.

Study Start Date:

June 2004

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age >/=18 years

First chronic phase, less than 6 months of duration

High Sokal's risk

Ph positive

No previous treatment or hydroxiurea only.

Performance status (ECOG/WHO) < 2

Written informed consent

Exclusion Criteria:

Age <18

Low or intermediate Sokal risk score.

More than 6 months from diagnosis.

Second chronic, accelerated or blastic phase

Scheduled allogeneic stem cell transplantation within 1 year from diagnosis.

Performance status (ECOG/WHO) > 2

Inability to provide written informed consent

Pregnancy

Formal refusal of any recommendation of a safe contraception

Alcohol or drug addiction

Altered hepatic or renal function as defined by AST/ALT or bilirubine > 3 times upper normal limits (UNL) and by creatinine > 20mg/L

Any other disease or condition that by the advise of the responsible physician would make the treatment dangerous for the patient or would make the patient ineligible for the study, including physical, psychiatric, social and behavioural problems.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00514488